A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03568318
Last Updated: 2025-12-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
1533 participants
INTERVENTIONAL
2018-08-09
2030-10-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Upon completion of enrollment of 810 participants in the Main Study, a supplemental study will continue to enroll adolescent participants (Adolescent Sub-study) until a total of 180 adolescent participants are enrolled in the overall study (Main Study + Adolescent Sub-study).
Approximately 1000 participants from M16-045 or M18-891 and approximately 500 participants from M16-047 will have the opportunity to enroll into the blinded Long-Term Extension (LTE) period (Week 260 - Week 524) after reaching Week 260 in their respective studies.
Randomization for the Main Study will be stratified by Baseline disease severity (validated Investigator Global Assessment Scale for Atopic Dermatitis \[vIGA-AD\] score of moderate \[3\] versus severe \[4\]), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other), and by age (adolescent \[ages 12 to 17\] versus adult \[ages 18 to 75\]). The separate randomization for the Adolescent Sub-study will be stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]) and by geographic region (US/Puerto Rico/Canada and Other).
At Week 16 of both the Main Study and the Adolescent Sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period, and participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. For the Main Study, the re-randomization will be stratified by Eczema Area and Severity Index (EASI) 50 responder status (Yes/No), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other) and by age (adolescent \[ages 12 to 17\] versus adult \[ages 18 to 75\]). For the Adolescent Sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other).
Starting at Week 4, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary The Primary Analysis for the Main Study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the Main Study and the Adolescent Sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo / Upadacitinib + Topical Corticosteroids
Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Placebo
Tablets taken orally once a day
Upadacitinib
Tablets taken orally once a day
Topical corticosteroids (TCS)
Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.
Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Upadacitinib 15 mg QD + Topical Corticosteroids
Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Upadacitinib
Tablets taken orally once a day
Topical corticosteroids (TCS)
Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.
Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Upadacitinib 30 mg QD + Topical Corticosteroids
Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Upadacitinib
Tablets taken orally once a day
Topical corticosteroids (TCS)
Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.
Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Long-Term Extension
Participants who reach Week 260 in Studies M16-045, M18-891, and M16-047 will have the opportunity to roll over into the blinded LTE period of M16-047 to continue receiving the same daily dose of upadacitinib for up to Week 524.
Upadacitinib
Tablets taken orally once a day
Topical corticosteroids (TCS)
Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.
Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Tablets taken orally once a day
Upadacitinib
Tablets taken orally once a day
Topical corticosteroids (TCS)
Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.
Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria.
* Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4.
* Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
* Documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit
Exclusion Criteria
* Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study
* Requirement of prohibited medications during the study
* Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
* Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
12 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Total Skin and Beauty Derm Ctr /ID# 200548
Birmingham, Alabama, United States
Clinical Research Center AL /ID# 201865
Birmingham, Alabama, United States
ACCEL Research Sites /ID# 213364
Birmingham, Alabama, United States
Advanced Dermatology and Skin Care Centre /ID# 213550
Mobile, Alabama, United States
Alliance Dermatology and MOHs Center, PC /ID#200540
Phoenix, Arizona, United States
Arizona Research Center, Inc. /ID# 200546
Phoenix, Arizona, United States
Clear Dermatology & Aesthetics Center /ID# 201257
Scottsdale, Arizona, United States
University of Arizona /ID# 201059
Tucson, Arizona, United States
Bakersfield Derma & Skin Cance /ID# 200892
Bakersfield, California, United States
Mosaic Dermatology /ID# 200553
Beverly Hills, California, United States
University of California Irvine /ID# 200902
Irvine, California, United States
Therapeutics Clinical Research /ID# 200593
San Diego, California, United States
Stanford University /ID# 200597
Stanford, California, United States
Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822
Aurora, Colorado, United States
Colorado Center for Dermatology, PLLC /ID# 203626
Centennial, Colorado, United States
Duplicate_Western States Clinical Research, Inc. /ID# 201702
Wheat Ridge, Colorado, United States
Dermatology Physicians of Connecticut /ID# 201004
Shelton, Connecticut, United States
Clearlyderm Dermatology /ID# 207709
Boca Raton, Florida, United States
Skin Care Research, LLC /ID# 200812
Boca Raton, Florida, United States
Clinical Research of West Florida, Inc /ID# 203643
Clearwater, Florida, United States
Florida Academic Centers Research and Education /ID# 200544
Coral Gables, Florida, United States
Tory P Sullivan, MD PA /ID# 201174
North Miami Beach, Florida, United States
Park Avenue Dermatology, PA /ID# 201012
Orange Park, Florida, United States
Precision Clinical Research /ID# 208734
Sunrise, Florida, United States
Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628
Boise, Idaho, United States
Northwestern University Feinberg School of Medicine /ID# 201646
Chicago, Illinois, United States
Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556
Skokie, Illinois, United States
DuPage Medical Group /ID# 202065
Wheaton, Illinois, United States
Deaconess Clinic Downtown /ID# 201001
Evansville, Indiana, United States
Indiana University /ID# 200515
Indianapolis, Indiana, United States
Epiphany Dermatology of Kansas LLC /ID# 203026
Overland Park, Kansas, United States
ORA, Inc. /ID# 202824
Andover, Massachusetts, United States
Tufts Medical Center /ID# 200570
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 200545
Boston, Massachusetts, United States
Clin Res Inst of Michigan, LLC /ID# 208020
Chesterfield, Michigan, United States
Michigan Center for Research Company /ID# 200560
Clarkston, Michigan, United States
MediSearch Clinical Trials /ID# 201006
Saint Joseph, Missouri, United States
Skin Specialists, PC /ID# 200573
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center /ID# 200918
Lebanon, New Hampshire, United States
Psoriasis Treatment Center of Central New Jersey /ID# 200714
East Windsor, New Jersey, United States
Juva Skin and Laser Center /ID# 200997
New York, New York, United States
J. Schwartz, MD, PLLC /ID# 202122
Troy, New York, United States
Bexley Dermatology Research /ID# 200899
Bexley, Ohio, United States
The Ohio State University /ID# 200542
Columbus, Ohio, United States
Vital Prospects Clinical Research Institute, PC /ID# 200901
Tulsa, Oklahoma, United States
Oregon Dermatology and Research Center /ID# 200601
Portland, Oregon, United States
University of Pittsburgh MC /ID# 206057
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital /ID# 200566
Providence, Rhode Island, United States
AAPRI Clinical Research /ID# 221134
Warwick, Rhode Island, United States
Rivergate Dermatology & Skin Care Center /ID# 201698
Goodlettsville, Tennessee, United States
Stones River Dermatology /ID# 204962
Murfreesboro, Tennessee, United States
Arlington Research Center, Inc /ID# 200559
Arlington, Texas, United States
Center for Clinical Studies /ID# 200582
Houston, Texas, United States
Progressive Clinical Research /ID# 201582
San Antonio, Texas, United States
Center for Clinical Studies - Webster TX /ID# 203186
Webster, Texas, United States
Advanced Clinical Research - Woseth Dermatology /ID# 213745
Salt Lake City, Utah, United States
Eastern Virginia Med School /ID# 200994
Norfolk, Virginia, United States
Dermatology Associates of Seattle /ID# 200717
Seattle, Washington, United States
University of Wisconsin - Madison /ID# 204933
Madison, Wisconsin, United States
St George Dermatology & Skin Cancer Centre /ID# 204788
Kogarah, New South Wales, Australia
Royal North Shore Hospital /ID# 204639
St Leonards, New South Wales, Australia
Westmead Hospital /ID# 205682
Westmead, New South Wales, Australia
Veracity Clinical Research /ID# 204793
Woolloongabba, Queensland, Australia
Fremantle Dermatology /ID# 205306
Fremantle, Western Australia, Australia
Medizinische Universitaet Innsbruck /ID# 210897
Innsbruck, Tyrol, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 209567
Linz, Upper Austria, Austria
Kepler Universitaetsklinikum GmbH /ID# 201075
Linz, Upper Austria, Austria
Medizinische Universitaet Wien /ID# 201080
Vienna, Vienna, Austria
UZ Brussel /ID# 203557
Jette, Brussels Capital, Belgium
UCL Saint-Luc /ID# 202028
Woluwe-Saint-Lambert, Brussels Capital, Belgium
UZ Gent /ID# 202030
Ghent, Oost-Vlaanderen, Belgium
IMTR - Grand Hopital de Charleroi /ID# 202029
Loverval, , Belgium
Kirk Barber Research, CA /ID# 200329
Calgary, Alberta, Canada
Dermatology Research Institute Inc. /ID# 200341
Calgary, Alberta, Canada
Alberta DermaSurgery Centre /ID# 205674
Edmonton, Alberta, Canada
Karma Clinical Trials /ID# 200339
St. John's, Newfoundland and Labrador, Canada
Eastern Canada Cutaneous Resea /ID# 200335
Halifax, Nova Scotia, Canada
Lynderm Research Inc. /ID# 200338
Markham, Ontario, Canada
DermEdge Research Inc. /ID# 200337
Mississauga, Ontario, Canada
The Centre for Clinical Trials /ID# 205404
Oakville, Ontario, Canada
Angela Montgomery Medicine Professional Corporation /ID# 212653
Ottawa, Ontario, Canada
SKIN Centre for Dermatology /ID# 200331
Peterborough, Ontario, Canada
The Center For Dermatology /ID# 205409
Richmond Hill, Ontario, Canada
Toronto Research Centre /ID# 205411
Toronto, Ontario, Canada
Research Toronto /ID# 205410
Toronto, Ontario, Canada
XLR8 Medical Research /ID# 205405
Windsor, Ontario, Canada
CHU Sainte-Justine /ID# 206013
Montreal, Quebec, Canada
Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403
Québec, Quebec, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 200330
Saint-Jérôme, Quebec, Canada
Chinese PLA General Hospital /ID# 206786
Beijing, Beijing Municipality, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669
Wuhan, Hubei, China
The First Hospital of China Medical University /ID# 209840
Shenyang, Liaoning, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132
Hangzhou, Zhejiang, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442
Hangzhou, Zhejiang, China
Beijing Friendship Hospital /ID# 207434
Beijing, , China
Xiangya Hospital Central South University /ID# 207510
Changsha, , China
Huashan Hospital of Fudan University /ID# 207437
Shanghai, , China
Fakultni nemocnice Plzen /ID# 202044
Pilsen, , Czechia
Sanatorium profesora Arenbergera /ID# 202082
Prague, , Czechia
Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze /ID# 202045
Prague, , Czechia
Chu de Nice-Hopital L'Archet Ii /Id# 205780
Nice, Alpes-Maritimes, France
AP-HM - Hopital de la Timone /ID# 206128
Marseille, Bouches-du-Rhone, France
CHRU Tours - Hopital Gatien de Clocheville /ID# 218209
Tours, Centre-Val de Loire, France
Hopital Saint-Andre /ID# 206129
Bordeaux, , France
Polyclinique Courlancy /ID# 201537
Reims, , France
Universitaetsklinik Heidelberg /ID# 202097
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Frankfurt /ID# 202095
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Muenster /ID# 202094
Münster, North Rhine-Westphalia, Germany
CMS3 Company for Medical Study /ID# 205195
Selters, Rhineland-Palatinate, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Bonn /ID# 202092
Bonn, , Germany
TFS Trial Form Support GmbH /ID# 202096
Hamburg, , Germany
Medizinische Hochschule Hannover /ID# 202098
Hanover, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194
Mainz, , Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093
Munich, , Germany
401 GSNA - 401 Army General Hospital /ID# 211963
Athens, Attica, Greece
Children's Hosp P. A. Kyriakou /ID# 217573
Athens, Attica, Greece
University General Hospital Attikon /ID# 201126
Athens, Attica, Greece
General Hospital Andreas Syggros /ID# 201123
Athens, Attica, Greece
Papageorgiou General Hospital Thessaloniki /ID# 202392
Stavroupoli (Thessalonikis), Thessaloniki, Greece
Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124
Thessaloniki, , Greece
Prince of Wales Hospital /ID# 205152
Hong Kong, , Hong Kong
Queen Mary Hospital /ID# 205146
Hong Kong, , Hong Kong
Oroshazi Korhaz /ID# 203525
Orosháza, Bekes County, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144
Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 201765
Debrecen, Hajdú-Bihar, Hungary
Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866
Debrecen, , Hungary
Allergo-Derm Bakos Kft. /ID# 205361
Szolnok, , Hungary
St James Hospital /ID# 201118
Dublin, Dublin, Ireland
South Infirmary Victoria University Hospital /ID# 201079
Cork, , Ireland
University Hospital Waterford /ID# 201253
Waterford, , Ireland
Soroka University Medical Center /ID# 206652
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 201611
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 201608
Tel Aviv, Tel Aviv, Israel
HaEmek Medical Center /ID# 201958
Afula, , Israel
Rabin Medical Center /ID# 201959
Petah Tikva, , Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014
Rome, Lazio, Italy
Istituto Clinico Humanitas /ID# 200739
Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690
Ancona, , Italy
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742
Catania, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II /ID# 200751
Napoli, , Italy
Chukyo Hospital /ID# 202311
Nagoya, Aichi-ken, Japan
Medical Corporation Matsuo Clinic /ID# 202312
Fukuoka, Fukuoka, Japan
Hiroshima University Hospital /ID# 201914
Hiroshima, Hiroshima, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic /ID#258665
Sapporo, Hokkaido, Japan
Hiramoto skin clinic /ID# 204048
Amagasaki-shi, Hyōgo, Japan
National Hospital Organization Sagamihara National Hospital /ID# 201658
Sagamihara-shi, Kanagawa, Japan
Queens Square Medical Center dermatology allergology /ID# 203850
Yokohama, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine /ID#258604
Kyoto, Kyoto, Japan
Kyoto University Hospital /ID# 201654
Kyoto, Kyoto, Japan
Tohoku University Hospital /ID# 206322
Sendai, Miyagi, Japan
Osaka Habikino Medical Center /ID# 204243
Habikino-shi, Osaka, Japan
Jichi Medical University Hospital /ID# 201913
Shimotsuke-shi, Tochigi, Japan
Juntendo University Hospital /ID# 202888
Bunkyo-ku, Tokyo, Japan
Tokai University Hachioji Hospital /ID# 201711
Hachioji-shi, Tokyo, Japan
Maruyama Dermatology Clinic /ID# 202350
Koto-ku, Tokyo, Japan
Yamate Dermatological Clinic /ID# 202130
Shinjuku-ku, Tokyo, Japan
Erasmus Medisch Centrum /ID# 202196
Rotterdam, South Holland, Netherlands
Academisch Medisch Centrum /ID# 202193
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen /ID# 202195
Groningen, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 202194
Utrecht, , Netherlands
Clinical Trials NZ /ID# 205336
Hamilton, , New Zealand
Haukeland University Hospital /ID# 201152
Bergen, Hordaland, Norway
Universitetssykehuset N-Norge, Harstad /ID# 201269
Harstad, Troms, Norway
Universitetssykehuset N-Norge, Tromso /ID# 201270
Tromsø, Troms, Norway
Rikshospitalet OUS HF /ID# 201271
Oslo, , Norway
Dr. Samuel Sanchez PSC /ID# 202002
Caguas, , Puerto Rico
Clinical Research Puerto Rico /ID# 203644
San Juan, , Puerto Rico
GCM Medical Group PSC - Hato Rey /ID# 202003
San Juan, , Puerto Rico
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372
Banská Bystrica, , Slovakia
Univerzitna nemocnica Martin /ID# 203851
Martin, , Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240
Nové Zámky, , Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373
Prešov, , Slovakia
Hospital Universitario de Puerto Real /ID# 200875
Puerto Real, Cadiz, Spain
Hospital General Universitario Alicante /ID# 200873
Alicante, , Spain
Hospital Santa Creu i Sant Pau /ID# 201325
Barcelona, , Spain
Hospital Universitario de la Princesa /ID# 201517
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 201135
Madrid, , Spain
Hospital Universitario La Paz /ID# 205438
Madrid, , Spain
Skane University Hospital Lund /ID# 201244
Lund, Skåne County, Sweden
Sahlgrenska University Hospital /ID# 201274
Gothenburg, Västra Götaland County, Sweden
Sodersjukhuset /ID# 201242
Stockholm, , Sweden
Karolinska University Hospital /ID# 201243
Stockholm, , Sweden
Barts Health NHS Trust /ID# 201044
London, London, City of, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 201193
London, London, City of, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 204642
London, London, City of, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 202052
Oxford, Oxfordshire, United Kingdom
NHS Tayside /ID# 202081
Dundee, Scotland, United Kingdom
NHS Greater Glasgow and Clyde /ID# 201374
Glasgow, Scotland, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 201106
Leeds, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Irvine AD, Prajapati VH, Guttman-Yassky E, Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Gold LFS, de Bruin-Weller M, Bieber T, Kabashima K, Rosmarin D, Sancho C, Calimlim BM, Grada A, Yang Y, Wu X, Levy G, Raymundo EM, Teixeira HD, Silverberg JI. Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Atopic Dermatitis: Phase 3 Randomized Clinical Trial Results Through 140 Weeks. Am J Clin Dermatol. 2025 Nov;26(6):1003-1016. doi: 10.1007/s40257-025-00975-3. Epub 2025 Sep 3.
Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.
Paller AS, Mendes-Bastos P, Siegfried E, Eichenfield LF, Soong W, Prajapati VH, Lio P, Simpson EL, Raymundo EM, Suravaram S, Hu X, Yang Y, Huang X, Calimlim BM, Platt AM, Su JC, Zheng M, Yamamoto-Hanada K, Teixeira HD, Irvine AD. Upadacitinib in Adolescents With Moderate to Severe Atopic Dermatitis: Analysis of 3 Phase 3 Randomized Clinical Trials Through 76 Weeks. JAMA Dermatol. 2024 Dec 1;160(12):1304-1313. doi: 10.1001/jamadermatol.2024.3696.
Silverberg JI, Leshem YA, Calimlim BM, McDonald J, Litcher-Kelly L. Psychometric evaluation of the Worst Pruritus Numerical Rating Scale (NRS), Atopic Dermatitis Symptom Scale (ADerm-SS), and Atopic Dermatitis Impact Scale (ADerm-IS). Curr Med Res Opin. 2023 Oct;39(10):1289-1296. doi: 10.1080/03007995.2023.2251883. Epub 2023 Sep 13.
Thyssen JP, Thaci D, Bieber T, Gooderham M, de Bruin-Weller M, Soong W, Kabashima K, Barbarot S, Luna PC, Xu J, Hu X, Liu Y, Raymundo EM, Calimlim BM, Nduaka C, Gamelli A, Simpson EL. Upadacitinib for moderate-to-severe atopic dermatitis: Stratified analysis from three randomized phase 3 trials by key baseline characteristics. J Eur Acad Dermatol Venereol. 2023 Sep;37(9):1871-1880. doi: 10.1111/jdv.19232. Epub 2023 Jun 21.
Paller AS, Ladizinski B, Mendes-Bastos P, Siegfried E, Soong W, Prajapati VH, Lio P, Thyssen JP, Simpson EL, Platt AM, Raymundo EM, Liu J, Calimlim BM, Huang X, Gu Y, Hu X, Yang Y, Su JC, Zheng M, Yamamoto-Hanada K, Teixeira HD, Irvine AD. Efficacy and Safety of Upadacitinib Treatment in Adolescents With Moderate-to-Severe Atopic Dermatitis: Analysis of the Measure Up 1, Measure Up 2, and AD Up Randomized Clinical Trials. JAMA Dermatol. 2023 May 1;159(5):526-535. doi: 10.1001/jamadermatol.2023.0391.
Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.
Silverberg JI, Simpson EL, Calimlim BM, Litcher-Kelly L, Li X, Sun X, Leshem YA. Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity Score Ranges for the Worst Pruritus Numerical Rating Scale and the Atopic Dermatitis Symptom and Impact Scales (ADerm-SS and ADerm-IS). Dermatol Ther (Heidelb). 2022 Dec;12(12):2817-2827. doi: 10.1007/s13555-022-00836-5. Epub 2022 Nov 4.
Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.
Reich K, Teixeira HD, de Bruin-Weller M, Bieber T, Soong W, Kabashima K, Werfel T, Zeng J, Huang X, Hu X, Hendrickson BA, Ladizinski B, Chu AD, Silverberg JI. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 5;397(10290):2169-2181. doi: 10.1016/S0140-6736(21)00589-4. Epub 2021 May 21.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-005126-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-047
Identifier Type: -
Identifier Source: org_study_id